MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911324250

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Occlusion (1984)

Event Date 04/18/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

It was reported that stent thrombosis occurred and the patient died.The patient presented with acute myocardial infarction.Vascular access was obtained via femoral artery.The heavily thrombosed, eccentric target lesion with a bend of >45 and <90 degrees was located in the tortuous mid left anterior descending artery.Following, pre-dilatation with a 2 x 12 mm balloon catheter at 12 atmospheres, a 2.50 x 24 mm promus element ¿ stent was advanced and successfully deployed.The procedure was completed after post-dilatation was performed with a 2.5 x 12 balloon catheter at 18 atmospheres.However, the following day, the patient was reported to have stent thrombosis and died.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7508000
• MDR Text Key: 108028809
• Report Number: 2134265-2018-04090
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: H7493911324250
• Device Catalogue Number: 39113-2425
• Device Lot Number: 0020333649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR